European Union Policy Corner
CTF Europe is committed to raising awareness for NF, expanding the NF research and clinical community, and advocating for research funding at the European level. The European Union (EU) plays a crucial role to coordinate European health policies designed to improve the health infrastructure and health systems, as well as to provide strategic funding for scientific excellence. The policy corner is intended at keeping you appraised of various European initiatives, policies, and funding opportunities that can be relevant to NF.
European Union’s Research & Innovation Programme, Horizon Europe
The European Union (EU) has an ambitious 7-year Research & Innovation funding programme (2021-2027), Horizon Europe, with a total budget of € 95.5 billion. Horizon Europe aims to widen the participation and strengthen the European Research Area by reforming and enhancing the European Research & Innovation system.
The European Innovation Council (EIC), represents the most ambitious innovation initiative the EU has taken with a budget of €10 billion for the period 2021-2027 and consists of one of Horizon Europe’s novelty. The EIC’s goal is to become a central pillar to realize and accelerate breakthrough innovation for rapid market growth for all types of innovators and innovative companies including SMEs and start-ups but also individuals, universities and research organizations. The EIC was formally launched on 18 March 2021; first calls have already been published in the EU’s Funding and Tender opportunities.
In terms of the broader Horizon Europe program, the Strategic Plan 2021-2024, published in March 2021, outlines the key strategic orientations that will define the future calls for projects for the first four years of the EU’s R&I Programme. The 2021-2022 Work Programme published in June 2021, identifies the main themes for the initial calls for projects under Horizon Europe.
Within the Health Cluster of the 2021-2022 Work Programme, grant-based funding will become available for collaborative research and innovation projects. The grants will be given to consortia developed under each call for project, the consistency of which can vary from universities, research institutes, public bodies, private for profit entities and other entities. EU funding is restricted to EU Member States, Associated Countries and some third countries where international cooperation agreements in the field of R&I are established with the EU.
Six main themes (entitled in the cluster Work programme as destinations) are outlined within the health cluster. Tackling diseases and reducing disease burden is defined as one of these main areas, which will be prioritized, particularly in the context of – among others – rare diseases. The Strategic Plan highlights the urgent need for research and innovation on new prevention, public health interventions, diagnostics, pharmacological and non-pharmacological therapies, as well improving existing prevention strategies towards achieving tangible impact for patients. International cooperation is recognized as a good opportunity to pool the best expertise and infrastructures to quickly advance R&I.
In future Horizon Europe projects, a logframe approach will be used, whereby, the projects will require to display a pathway to impact. Thus, each project will need to demonstrate how the expertise brought into a project (input), will lead to R&I results (output), that can become available for immediate use or uptake of R&I results (outcome) to provide wider benefits for the society (impact). On 23 June 2021, the first 24 Health Cluster calls have been launched, available in the EU’s Funding and Tender opportunities. Interested consortia have until 21 September 2021 to submit their proposals for grants. For rare diseases, a call for project entitled ‘Development of new effective therapies for rare diseases’ is foreseen to be launched on 6 October 2021.
As EU funding is expected to become gradually available, there will be interesting opportunities for European NF Researchers to pursue collaborative R&I funding in Europe to drive forward research for NF. The Europe’s Beating Cancer Plan is also streamlining the future support of research in oncology, by proposing policies for building capacity, fostering innovation and supporting clinical research.
Launch of the European Commission’s Knowledge Center on Cancer
On 30 June 2021, the European Commission launched its Knowledge Centre on Cancer (KCC), a tool aiming to bridge the scientific and technical evidence of the Europe’s Beating Cancer Plan and the Horizon Europe Mission on Cancer. The KCC will be a patient-citizen centric initiative, operated by the European Commission’s Joint Research Centre aiming to assist the European Commission initiatives and actions in the field of cancer. The KCC will also provide in-house competence on cancer prevention, registry data and guidelines and quality assurance for cancer screening, diagnosis and care.
European Parliament’s Beating Cancer (BECA) Committee publishes Draft Report
The European Parliament’s Beating Cancer (BECA) Committee published on 28 June a Draft Report addressing the EU’s policies in the field of Cancer. The Report will feed into the implementation of the European Commission’s Beating Cancer Plan, particularly on the related policies developed at European level. The draft report calls for:
- the development of a more sustainable environment for conducting research into the repurposing of medicines for cancer treatment;
- supports the recommendation of the Joint Action on Rare Cancers for the creation of a European unique patient identifier, to monitor the long-term outcomes in childhood cancer survivors in a cross-border setting;
- emphasises the need to secure sustained long-term funding for the European Reference Networks and calls on Member States to fully integrate ERNs into their national healthcare systems;
- supports a clear and specific EU funding stream to be dedicated to pediatric cancer research; and
- calls for an ambitious revision of pediatric and orphan medicines regulations to ensure children can have faster access to pediatric and orphan drugs, while recommending an increase of 20 % in the available new pediatric cancer drugs by 2027
The Draft Report will be presented on 15 July before the European Parliament’s Beating Cancer Committee, and is subject to change, following the consultation process of the Special Committee members, which open until September. The Draft Report is expected to be adopted in December 2021.
Breakthrough on EU Health Technology Assessment (HTA) Regulation
After months of negotiations, the EU’s co-legislators reached a deal on the legislative proposal for a Health Technology Assessment Regulation, a future EU law aiming to reinforce the HTA cooperation among Member States and to establish a permanent and sustainable cooperation in the EU for joint clinical assessments linked to new medicines and medical devices. The Regulation is expected to be directly applicable across the EU27 Member States 3 years after its formal publication, still outstanding until the EU’s procedural steps following the deal can be concluded. Many prominent associations have issued their preliminary thoughts on the compromise reached, including EFPIA, MedTech Europe and EURORDIS. Secondary EU legislation can also be expected in the future in the form of Implementing Acts that will define the joint clinical assessment and joint scientific consultation criteria, as well as the general procedural rules and content for clinical assessment reports.
European Commission launches Open Access Publishing Platform for scientific papers
As a means to enable researchers to publish any research they wish to share, the European Commission launched an Open Access Publishing Platform, which will enable the transparent publication of scientific papers with an open invited peer review. This platform would aim to be a scientifically rigorous publishing service for researchers involved and having received funding from the EU’s R&I funding programs.
